New Echocardiographic Parameters for Assessment of Longitudinal Left Ventricular Function (LAX)
This study is currently recruiting participants.
Verified January 2011 by University of Heidelberg
Sponsor:
University of Heidelberg
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01275963
First received: January 12, 2011
Last updated: February 16, 2011
Last verified: January 2011
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Purpose
Assessment of left ventricular systolic function is the most frequent indication for routine echocardiography. Qualitative eyeball method and biplane modified Simpson's rule, both measuring radial ventricular function, are the currently recommended methods to meet this challenge. Due to the complexity of the myocardial architecture, global left ventricular function also has longitudinal and torsional components.
The aim of this study is to evaluate new echocardiographic parameters for longitudinal left ventricular function. A special focus is set on strain imaging by speckle tracking, which is a relatively new technique. Patients with different cardiac pathologies (e. g. dilated cardiomyopathy, coronary artery disease, diastolic dysfunction) will be included and compared to healthy individuals.
| Condition |
|---|
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Cardiovascular Pathology |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | New Echocardiographic Parameters for Assessment of Longitudinal Left Ventricular Function |
Resource links provided by NLM:
Further study details as provided by University of Heidelberg:
Primary Outcome Measures:
- left ventricular longitudinal systolic strain (LV-LSS) in all patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]left ventricular longitudinal systolic strain (LV-LSS) is measured in all patients by speckle tracking strain imaging
Secondary Outcome Measures:
- mitral annular plane systolic excursion (MAPSE) in all patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]MAPSE is measured by M-Mode echocardiography
- mitral annular systolic velocity (MASV) in all patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]MASV is derived from tissue doppler
- diastolic left ventricular function in all patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]Diastolic function is assesed by mitral inflow, mitral annulus velocity, pulmonary vein flow and velocity of flow progression.
- pulmonary artery systolic pressure (PASP) in all patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]PASP is derived from Tricuspid valve regurgitation velocity
- left ventricular ejection fraction (LVEF) in all patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]EF is measured by modified Simpson's rule (biplane)
| Estimated Enrollment: | 160 |
| Study Start Date: | January 2011 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Control
Healthy individuals without structural heart disease
|
|
CAD
Patients with coronary artery disease
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|
DCM
Participants with dilated cardiomyopathy
|
|
HNCM
Patients with hypertrophic non-obstructive cardiomyopathy
|
|
HOCM
Patients with hypertrophic obstructive cardiomyopathy
|
|
RCM
Patients with restrictive cardiomyopathy
|
|
Amyloidosis
Patients with cardiac manifestation of amyloidosis
|
|
HFPEF
Patients with heart failure with preserved ejection fraction (diastolic heart failure)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Healthy individuals and patients with various cardiac pathologies, who undergo routine echocardiography at our department
Criteria
Inclusion Criteria:
- persons of 18 years and older who receive a transthoracic echocardiography at our department
- written consent
Exclusion Criteria:
- permanent pacemaker rhythm
- moderate/severe valvular heart disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275963
Contacts
| Contact: Derliz Mereles, M.D. | +49622156 ext 8852 | derliz.mereles@med.uni-heidelberg.de |
| Contact: Alexander Hess, M.D. | +49622156 ext 38675 | alexander.hess@med.uni-heidelberg.de |
Locations
| Germany | |
| University of Heidelberg | Recruiting |
| Heidelberg, Germany, 69120 | |
Sponsors and Collaborators
University of Heidelberg
Investigators
| Principal Investigator: | Alexander Hess, M.D. | University of Heidelberg |
| Principal Investigator: | Derliz Mereles, M.D. | University of Heidelberg |
More Information
Additional Information:
No publications provided
| Responsible Party: | Derliz Mereles, M.D., University of Heidelberg |
| ClinicalTrials.gov Identifier: | NCT01275963 History of Changes |
| Other Study ID Numbers: | S-401/2010 |
| Study First Received: | January 12, 2011 |
| Last Updated: | February 16, 2011 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Heidelberg:
|
Echocardiography Strain imaging Ventricular Dysfunction Cardiomyopathy Longitudinal left ventricular function |
ClinicalTrials.gov processed this record on October 18, 2012
